Efficacy and Safety of Dexketoprofen/Vitamin B vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II — WHIPLASH  

Acute Low Back Pain Clinical Trial

Official title: Efficacy and Safety of the Combination Dexketoprofen / Vitamin B vs Dexketoprofen in the Treatment of Pain in Patients With Post-traumatic Cervical Sprain Grade I-II of the Quebec Scale.

Status Completed

Clinical Trial Summary

Phase IIIb, multicenter, prospective, randomized, double-blind study to evaluate the fixed combination of Desketoprofen / Vitamin B in the management of acute pain in patients with cervical sprain grade I-II of the Quebec scale.

Clinical Trial Description

Study to evaluate the efficacy and safety of the Dexketoprofen / Vitamin B combination versus dexketoprofen for the management of acute pain secondary to post-traumatic cervical sprain grade I-II of the Quebec scale, evaluated by means of the Visual Analogue Scale (VAS). To compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire in Spanish version on days 3, 5, and 7 compare to its baseline measurement between the treatment groups. Compare the proportion of subjects requiring rescue medication during the study between treatment groups. Describe the frequency and intensity of adverse events presented during the study. ;

Related Conditions & MeSH terms

• Acute Low Back Pain
• Low Back Pain

• NCT number: NCT05001555
• Study type: Interventional
• Source: Laboratorios Silanes S.A. de C.V.
• Status: Completed
• Phase: Phase 3
• Start date: November 23, 2021
• Completion date: April 25, 2023